NCT06954168

Brief Summary

Tobacco use is a major cause of death resulting from cancer, cardiovascular diseases, and pulmonary disorders. It is also a risk factor for respiratory and other infections, osteoporosis, diabetes, reproductive disorders, adverse surgical outcomes and delayed wound healing, as well as duodenal and gastric ulcers \[1\]. Studies project that the number of deaths due to smoking will rise to 8.4 million by 2030 \[2\]. According to the Tobacco Atlas, in Turkey, 83,100 people die each year due to smoking-related causes. The negative effects of smoking are not limited to chronic diseases; it can also affect the quality of daily life. In a study involving 3,516 participants, it was reported that both male and female smokers experienced significantly greater difficulty falling asleep compared to non-smokers. They also suffered from non-restorative sleep, frequent awakenings during the night, and difficulty falling back asleep \[3\]. Furthermore, literature has demonstrated a significant relationship between smoking and perceived stress \[4\]. Perceived stress is defined as "the feelings or thoughts an individual has about how much stress they are under during a particular period" \[5\]. Although smoking may temporarily alleviate perceived stress, studies suggest it may actually lead to negative emotional states or exacerbate stress in the long run \[6, 7\]. In addition, it has been found that smokers tend to feel more tired and become fatigued more quickly compared to non-smokers \[8, 9\]. The majority of smokers begin smoking during adolescence \[10\]. In their study, Burt et al. reported that 71% of smokers started smoking at or before the age of 18 \[11\]. The university period is a critical phase in young individuals' lives, and habits formed during this time can have long-term health consequences. Smoking can affect not only health but also academic performance \[12\]. Factors such as stress \[13\], sleep quality \[14\], and fatigue \[15\], which have previously been studied in smokers, have also been shown to negatively impact academic achievement. Although academic success will not be directly evaluated in our study, considering the target population, the potential secondary effect of smoking on academic performance further underscores the significance of our research. This study is designed to compare university students who smoke and those who do not in terms of sleep quality, fatigue, and perceived stress levels. Although there are existing studies that examine these parameters individually or in different populations, to our knowledge, no study has simultaneously assessed all of these factors in a university student sample. Most studies in this field focus on the general population; however, university students represent a specific group due to their stressful academic lives, social pressures, and lifestyle changes. The originality of our study lies in its focus on university students and its comprehensive approach to examining multiple variables concurrently. In this context, the planned research will provide more specific and detailed insights into the factors associated with nicotine dependence and their interrelationships.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
528

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2025

Completed
24 days until next milestone

Study Start

First participant enrolled

May 25, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 27, 2025

Completed
Last Updated

May 13, 2025

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

April 24, 2025

Last Update Submit

May 12, 2025

Conditions

Outcome Measures

Primary Outcomes (4)

  • The Fagerstrom Test for Nicotine Dependence

    only once

  • The Pittsburgh Sleep Quality Index Scoring

    only once

  • The Fatigue Assessment Scale

    only once

  • The Perceived Stress Scale

    only once

Study Arms (2)

University students who smoke

non-smoking university students

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

University Students

You may qualify if:

  • be an actively enrolled undergraduate student

You may not qualify if:

  • Have a diagnosed sleep disorder such as sleep apnea, insomnia or narcolepsy.
  • Have mental health problems such as diagnosed depression, anxiety disorders or bipolar disorder.
  • Chronic diseases such as diabetes, hypertension, asthma.
  • Conditions that may independently affect sleep, fatigue or stress, such as night shift work and pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Ph.D

Study Record Dates

First Submitted

April 24, 2025

First Posted

May 1, 2025

Study Start

May 25, 2025

Primary Completion

August 30, 2025

Study Completion

October 27, 2025

Last Updated

May 13, 2025

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share